Bristol Myers Squibb sues seven generic drugmakers in Delaware over Camzyos patents

Bristol Myers Squibb (NYSE: BMY) said in its 10-Q filed July 30, 2026 that it has sued seven generic drug companies in the U.S. District Court for the District of Delaware over its Camzyos patents. The defendants are Aurobindo Pharma Ltd., Zenara Pharma Pvt. Ltd., Micro Labs Ltd., Dr. Reddy's Laboratories Limited, Annora Pharma Private Limited, Apotex Inc. and MSN Laboratories Pvt. Ltd. BMS is the plaintiff, and no individual is named.

In May and June 2026, BMS received notice letters from each company saying it had filed an abbreviated new drug application with a paragraph IV certification. Each filing seeks approval to market a generic mavacamten product, the drug sold as Camzyos, in the U.S. before certain BMS patents expire. BMS responded by starting a patent infringement action against each one. The 10-Q gives no case numbers or filing dates.

What is at stake for Camzyos

The 10-Q does not list the patents at issue or describe the generic companies' arguments, and it reports no rulings, hearing dates or trial dates in the Camzyos cases. It notes that Camzyos is sold only through a restricted program, the Camzyos REMS Program, under which only certified pharmacies may dispense it to authorized patients.

BMS's 2025 annual report puts the estimated minimum market exclusivity date for Camzyos at 2036 in the U.S. and 2034 in the EU and Japan. It says the U.S. patent term restoration application was granted, providing a patent expiry of 2036. Supplementary protection certificates have been granted in France, Germany, Italy and Spain with an estimated expiry of 2038, and applications are pending in the UK and Japan. The same report warns that there can be no assurance a product will enjoy market exclusivity for the full period in the estimate, and that the length of exclusivity is impossible to predict with certainty because of the uncertainties of patent litigation.

The Eliquis case in Delaware

The 10-Q describes a separate case in the same court. In November 2025, BMS received a notice letter from Azurity Pharmaceuticals, Inc., which had filed a 505(b)(2) application with a paragraph IV certification to market apixaban products in the U.S. Azurity challenges a formulation patent listed in the Orange Book for Eliquis, not the composition of matter patent. BMS and its partner Pfizer responded with a patent infringement action against Azurity in Delaware. The 10-Q gives no ruling or trial date for it.

Eliquis already faces a set date in the U.S. The annual report says BMS and Pfizer settled with a number of generic companies that challenged Eliquis patents and won against others at the trial and appellate levels. Under those settlements, the generic companies that settled are permitted to launch in 2028, subject to additional challenges.

Eliquis in Europe

BMS is also fighting companies seeking to launch generic apixaban in Europe before the composition-of-matter patent and its supplementary protection certificates expire. The 10-Q lists a final negative decision in the UK, where generics are now on the market, and final positive decisions in Norway, Spain, Sweden and Switzerland. Initial negative decisions came in Finland, Ireland and Slovakia; appeals courts overturned the Finnish and Irish decisions and sent them back, and the Irish case has since settled. One or more generics have entered the market in Poland while proceedings are pending. The annual report says the EU apixaban composition of matter patents and related certificates expire in November 2026.

What the company says

BMS says it is vigorously defending the proceedings in which it is named as a defendant and believes it has substantial claims or defenses in each matter. It also warns that failure to enforce its patent rights "would likely result in substantial decreases in the respective product revenues from generic competition."

The 10-Q says contingency accruals are recorded only when a loss is probable and can be reasonably estimated. It gives no estimate of cost for any of the patent cases. Total revenues were $12,973 million in the second quarter of 2026, against $12,269 million a year earlier.

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